Cervical cuff

ABSTRACT

A cervical cuff for holding closed an incontinent cervix, comprising a stiffly flexible substantially inelastic support ring having a central axis and an inner and an outer peripheral wall. The inner wall forms an opening to receive the neck of the cervix. A first and second elastic impermeable membrane extends around and is mounted to the inner and outer walls respectively so as to form a first and second laterally expansible chamber. Inflation of the chambers extends the membranes so that the inner membrane engages the cervical neck inside the opening, and the outer membrane engages body tissue surrounding and spaced from the cervical neck. The ring is thereby retained in the body and the neck is held closed inside the ring.

United States Patent [1 1 Yosowitz et a].

[ CERVICAL CUFF [75] Inventors: Edward E. Yosowitz, Wichita Falls,

Tex.; Donald K. McGhan, Santa Barbara, Calif.

[73] Assignee: Heyer-Schulte Corporation, Santa Barbara, Calif. by saidMcGhan [22] Filed: Jan. 3, 1972 [21] Appl. No.: 214,541

521 U.S. Cl 128/346, 251/5, 46/90,

128/325, 128/361 [51] Int. Cl A6lb 17/42 [58] Field of Search 128/346,129, 127,

128/130, 131, 344, 2.05 C, 325, 326, DIG. 20, DIG. 25, 327, 349 B, 361;29/243.56; 269/20, 328; 277/21, 38.3, 58; 251/5; 46/87, 88, 9O

OTHER PUBLICATIONS l-largest & Derrick, An Artificial Urethral SphincterJune 26, 1973 Primary Examiner-Richard A. Gaudet AssistantExaminer-Henry J. Recla Attorney- D. Gordon Angus and Donald D. Mon

[57] ABSTRACT A cervical cuff for holding closed an incontinent cervix,comprising a stiffly flexible substantially inelastic support ringhaving a central axis and an inner and an outer peripheral wall. Theinner wall forms an opening to receive the neck of the cervix. A firstand second elastic impermeable membrane extends around and is mounted tothe inner and outer walls respectively so as to form a first and secondlaterally expansible chamber. Inflation of the chambers extends themembranesso that the inner membrane engages the cervical neck inside theopening, and the outer membrane engages body tissue surrounding andspaced from the cervical neck. The ring is thereby retained in the bodyand the neck is held closed inside the ring.

9 Claims, 7 Drawing Figures PATENTEDJUNZB ma 3.741.216

unov/o ooaaa DDOOOOOQG CERVICAL CUFF This invention relates to acervical cuff for an incontinent cervix.

The problem of incontinent cervices has been a nagging one in thesurgical field for a long time. Speaking generally, an incontinentcervix is one which cannot contain the products of conception during thesecond trimester. Its clinical manifestations including bulging of thefetal membranes, absence of uterine contractions, and absence ofbleeding, leading to rapid and painless second trimester abortion. Therehave been extensive attempts to manage the incontinent cervix which havegenerally been centered on three approaches. The first approach issurgical, which includes the techniques of cerclage, trachelorrhaphy,and isthmorrhaphy. The second approach is hormone therapy usingprogestational agents-and the third approach is mechanical devices suchas certain kinds of pessaries.

There are disadvantages in all of the above methods. For example,surgical complications of cerclage include the risk of uterine rupturedue to failure to remove the restraint in the presence of strong uterinecontractions and amnionitis, endometritis, sepsis, anesthesia risks toboth mother and fetus, and cervical amputation. Hormonal therapy has metwith only moderate success. The use of a pessary may involve problems ofdischarge, discomfort, erosion, and bleeding.

In all of the foregoing three approaches, there is also involved thesignificant factor of economic cost, bothas to the time required for theprocedure, and the expenses surrounding it. To a person with limitedfunds,

however successful any of these techniques may be, it

is simply too expensive.

The inflatable cuff of this invention has been designed to provide theobstetrician with a safe and easy method of treating cervicalincompetence. The device is simple to insert; it lacks the majorcomplications listed above, and it is very-economical. It can beinserted in the doctors office and does not require hospitalization.

A cervical cuff according to this invention comprises a stiffly flexiblesubstantially inelastic support ring having a central axis and an innerand an outer peripheral wall. The inner wall forms an opening to receivethe neck of the cervix. A first and a second elastic impermeablemembrane extends around and is mounted to the said inner and outer wallrespectively, forming a first and a'second laterally expansible chamber.Inflation of the chambers extends the membranes laterally so that theinner membrane engages the cervical neck inside the opening and closesthe neck. The outer membrane engages body tissue surrounding and spacedfrom the cervical neck whereby to retain the ring in the body.

According to a preferred but optional feature of the invention, valvemeans is provided in fluid communication with each of said chambers toadmit and retain fluid under pressure therein.

The above and other features of this invention will be fully understoodfrom the following detailed description and the accompanying drawings inwhich:

FIG. I is an axial cross-section taken at line 1-1 of FIG. 1;

FIG. 2 is a top view taken at line 2-2 of FIG. 1;

FIG. 3 is an axial cross-section of the presently preferred embodimentof the invention;

FIGS. 4 and 5 are axial cross-sections of portions of FIG. 3;

FIG. 6 is a top view of FIG. therein; and

FIG. 7 is a fragmentary cross-section showing another means forsupplying fluid to the chambers.

In FIG. 1 there is shown a cervical cuff 10, according to the inventionwhich includes a stiffly flexible, substantially inelastic support ring11, having an inner wall 12 an outer wall 13 and a central axis 14 withwhich the inner and outer walls are coaxial. The inner wall forms anopening 15 to receive the neck of the cervix.

A first and a second membrane 16, 17 are attached to the ring at theinner and outer wall respectively so as to form therewith an inner andan outer chamber 18, 19 respectively. The membranes are flexible andelastic so that the chambers are' expansible when fluid is introducedtherein. They are also impermeable.

The entire device is preferably made of silicone rubber because of thetolerances of tissue to this material of construction. The support ringwill be substantially inelastic and stiffly flexible because of itsrelatively heavy cross-section, while the membranes are laterallyexpansible because of their relatively thinner crosssection. Thesesections will be selected with a view to the tensile properties of theparticular formulation of silicone rubber which is used. A suitable ringwill have an inner diameter of l 1% inches, an outer diameter of 2 9%inches and an axial thickness of inch. The inner membrane will inflateto a l rt; inch diameter and the outer membrane will inflate to a 3 inchdiameter.

In case a self-sealing structure is used, the chambers may be inflatedsimply bypiercing the support ring or either of themembranes with a fineneedle and then injecting a fluid such as saline solution, relying upontendency of the rubber to close on itself tokeep the fluid confined.Alternatively, check valves 20, 21 of any desired construction can bebuilt into the ring and connected by channels 22, 23 to the chambers.These are only two examples of the many alternative means by which thechambers may be filled with fluid under pressure. Another will be shownin connection with the embodiment of FIGS. 3-6.

The device of FIGS. 3-6 is the presently preferred embodiment of theinvention. It is a cervical cuff 25 with a support ring 26 having aninner wall 27 an outer wall 28, and a central axis 29. The inner wallforms a central opening 30. 1

Peripheral grooves 31, 32 are formed in an inner and outer wallsrespectively. These are semi-circular in cross-section and receive firstand second membranes 33, 34 in the form of continuously sealedcircularly sectioned flexible peripheral tubes whose outer dimensionsare congruent to those of the groove into which they fit. The firstmembrane 33 is shown in FIG. 3 seated in groove 31 with a plurality ofprotuberances 35 facing inwardly. The second membrane 34 is shown inFIG. 5 with a plurality of protuberances 36 on its outside periphery,whereby the protuberances will face outside the ring and engage andimprove the contact with the tissues against which it abuts when in use.When not filled with fluid (either gas under pressure, or a trappedliquid), the membranes will yield to pass adjacent objects, but whenfilled they become rigid at or even beyond their illustrated'size to fixthe cuff in place. i

3 taken at lines 6-6 Suitable dimensions for the ring are: innerdiameter, l k inches, outer diameter, 2 1% inches, axial thickness 1inch. Relaxed outer tubular diameter of outer membrane one-half inch,its peripheral diameter equally 3 inches. Relaxed outer tubular diameterof inner membrane, three-eighths inches, diametrica] central opening, 1A; inches. Protuberance one-sixteenth inch spherical domes on A inchcenters.

Valves 37, 38 are provided in the membranes 33, 34 respectively and maybe typical bladder type valves such as found in basketballs andfootballs. These may be vulcanized in place and typically will include abase 39 and a overlying diaphragm 40 which can be displaced by a needleto pass the fluid. Alternatively, the membranes may be provided withtubings integral therewith which can be led and connected to a source offluid under pressure and then the tube may be tied, fused or otherwiseclosed with the excess tube cut off to size after installation.

In FIG. 7, a tubular membrane 45 is shown with a conduit 46 connected toit to pass fluid. This conduit may be closed in any desired manner.

In the device of FIGS. 3-6, the materials of construction may again besilicone rubber, the cross-sectional area of the support ring being suchas to render it stiffly flexible and substantially inelastic while thewall thickness of the membranes is such as to permit the chambers to beexpanded so as to accomplish the purpose of the invention.

The fluid for insertion may be gas or liquid, but liquid is preferred.The term inflation" as used herein encompassed not only a stretching ofthe membrane, but also the rigidity of a membrane in its normalconfiguration, its prior condition having been slack, such as by therebeing air in the membranes of FIG. 3, followed by filling them full ofliquid.

The use of the devices are extremely simple. While the membranes areuninflated, the neck of the cervix is grasped and pulled through thecentral opening and the ring is thrust upwardly to its final location.Then the chambers are inflated so as to bring the membranes into contactwith the tissue which they are to engage. The fluid is retained eitherby check valves, by cutting, tying or fusing the conduits, or simply bywithdrawing the needle from a self-sealing structure. The cuff is thenin place and will remain fixed there until it is time for it to beremoved. The technique of insertion is simple, does not requirehospitalization and the device itself is elegantly simple andinexpensive.

This invention is not to be limited by the embodiments shown in thedrawings and described in the description, which are given by way ofexample and not of limitation, but only in accordance with the scope ofthe appended claims.

We claim:

1. A cervical cuff for holding closed the neck of an incontinent cervixcomprising: a stiffly flexible, substantially inelastic support ringhaving a central axis and an inner and an outer peripheral wall, theinner wall forming an opening to receive the neck of the cervix; a firstand a second elastic fluid-tight membrane extending around and mountedto the said inner and outer wall respectively, forming a first and asecond laterally expansible chamber, means permitting the inflation ofsaid first and second chambers whereby inflation of said chambersextends said membranes laterally so that the inner membrane engages acervical neck inside the opening, and the outer membrane engages bodytissues surrounding and spaced from the cervical neck, whereby to retainthe ring in the body while the inner membrane holds closed the cervicalneck.

2. A cervical cuff according to claim 1 in which said means permittingthe inflation of said chambers is valve means provided in fluidcommunication with each of said chambers to admit and retain fluid underpressure therein.

3. A cervical cuff according to claim 1 in which the membranes comprisebodies of revolution joined at parallel edges to the ring.

4. A cervical cuff according to claim 1 in which the membranes comprisecontinuous closed tubes an in which the inner and outer walls havegrooves to receive said tubes.

5. A cervical cuff according to claim 1 in which the inner one of saidmembranes has protuberances on its inner surface and in which the outermembrane has protuberances on its outer surface.

6. A cervical cuff according to claim 1 in which said means permittingthe inflation of said chamber is valve means provided in each of saidmembranes comprising a check valve.

7. A cervical cuff according to claim 6 in which the chambers.

' i i k

1. A cervical cuff for holding closed the neck of an incontinent cervixcomprising: a stiffly flexible, substantially inelastic support ringhaving a central axis and an inner and an outer peripheral wall, theinner wall forming an opening to receive the neck of the cervix; a firstand a second elastic fluid-tight membrane extending around and mountedto the said inner and outer wall respectively, forming a first and asecond laterally expansible chamber, means permitting the inflation ofsaid first and second chambers whereby inflation of said chambersextends said membranes laterally so that the inner membrane engages acervical neck inside the opening, and the outer membrane engages bodytissues surrounding and spaced from the cervical neck, whereby to retainthe ring in the body while the inner membrane holds closed the cervicalneck.
 2. A cervical cuff according to claim 1 in which said meanspermitting the inflation oF said chambers is valve means provided influid communication with each of said chambers to admit and retain fluidunder pressure therein.
 3. A cervical cuff according to claim 1 in whichthe membranes comprise bodies of revolution joined at parallel edges tothe ring.
 4. A cervical cuff according to claim 1 in which the membranescomprise continuous closed tubes an in which the inner and outer wallshave grooves to receive said tubes.
 5. A cervical cuff according toclaim 1 in which the inner one of said membranes has protuberances onits inner surface and in which the outer membrane has protuberances onits outer surface.
 6. A cervical cuff according to claim 1 in which saidmeans permitting the inflation of said chamber is valve means providedin each of said membranes comprising a check valve.
 7. A cervical cuffaccording to claim 6 in which the valve means comprises a deflectablediaphragm.
 8. A cervical cuff according to claim 1 in which said meanspermitting the inflation of said chamber is conduit means provided tothe respective chambers for filling the same.
 9. A cervical cuffaccording to claim 1 in which said means permitting the inflation ofsaid chambers comprises a self-sealing wall provided to the respectivechambers.